Medical Marijuana, Inc. investment company AXIM® Biotechnologies is revolutionizing the way you think about chewing gum with their line of cannabinoid-infused gum. The company is entering clinical trials for a number of formulations of their functional chewing gum for conditions like irritable bowel syndrome and the pain and spasticity associated with multiple sclerosis.
With the development of cannabinoid-based pharmaceutical chewing gum products, AXIM® is pioneering the use of cannabinoid medications and radically changing the way we think about chewing a piece of gum.
CanChew® and the Patent on Cannabinoid Chewing Gum
CanChew® is a non-psychoactive, CBD-based daily use dietary supplement that provides 50 mg of hemp oil and 10 mg of CBD per serving. Because CanChew® is created using hemp, it is legal to purchase and use in all 50 U.S. states and in over 40 countries internationally, making CanChew® one of the first widely marketed cannabinoid-based products available.
Medical Marijuana, Inc. initially acquired a significant stake in CanChew® in 2012, selling it through its distribution branch HempMeds®. Since then, this CBD-infused chewing gum has become one of Medical Marijuana, Inc.’s most successful products.
Soon after, Medical Marijuana, Inc. and AXIM® Biotechnologies began eying the pharmaceutical market for their functional chewing gum. AXIM® Biotechnologies received the patent for controlled release cannabinoid chewing gum in 2015 – a patent that was extended this past year.
Prior to this new extension, Patent 9,023,322 only claimed gum products as a delivery mechanism for cannabidiol (CBD), a well-known cannabinoid. This extension of AXIM® Biotech’s patent now allows AXIM® exclusivity on delayed-release gum containing any cannabinoids.
“This patent will enable AXIM to include any of the at least 85 different cannabinoid compounds found in the cannabis plant, including CBD and THC, into its multiple cannabinoid controlled-release chewing gum products,” said Medical Marijuana, Inc. CEO Dr. Stuart Titus of the extension. “As investors in AXIM, we are enthusiastic about how the Company continues to move forward as a leader in cannabinoid research and development.”
MedChew® RX for Multiple Sclerosis
AXIM® Biotechnologies is looking to secure MedChew® Rx as a novel, patented delivery method for cannabinoids in the treatment of patients with multiple sclerosis (MS).
MedChew® RX – formulated with 5 mg of cannabidiol (CBD) and 5 mg of tetrahydrocannabinol (THC) – will soon undergo Phase 3 clinical trials for the relief of pain and spasticity associated with MS. Once approved by the European Medicines Agency (EMA), MedChew Rx™ will be available across the European Union.
AXIM® Biotechnologies will be conducting their clinical trial on MedChew® Rx at the Free University of Amsterdam, The Netherlands. The study will be performed in collaboration with the University of Plymouth, UK, and an academic center in the U.S. The anticipated duration of the clinical trials prior to FDA/ EMA registration is approximately twelve months.
“We’re extremely pleased that AXIM has received the financing it needs to continue clinical efforts with the Company’s two near-term prospects. Further, the financing will allow the AXIM team of visionaries and world leaders, with proven track records, to create further cannabinoid-based innovations that may address additional indications,” said Medical Marijuana, Inc. Chief Executive Officer Dr. Stuart Titus.
The potential economic impact for MedChew® Rx is estimated at $4.8 billion USD for these symptoms of MS.
CanChew® Plus for Irritable Bowel Syndrome
AXIM® is also running clinical trials on its CanChew® Plus cannabinoid chewing gum to determine the formulation’s potential as a treatment for Irritable Bowel Syndrome (IBS). The study will test two different potencies of CanChew® gum to choose the ideal dosing for the next phase of trials.
AXIM has also developed CanChew Plus™ CBD containing gum with improved delivery system and increased doses of CBD that is set to begin clinical trials in the EU. The goal of these studies is to begin to determine the potential reduction of irritable bowel syndrome (IBS) symptoms in suffering patients.
“We congratulate the AXIM team on reaching another major milestone in the Company’s continued efforts to research new solutions using cannabinoid-based drugs,” said Dr. Stuart Titus, CEO of Medical Marijuana, Inc. “We are very excited about the new formulation of CanChew Plus, which we feel will offer superior bioavailability versus our prior rendition of CanChew.”
Wageningen University in the Netherlands is slated to conduct the CanChew® Plus studies. Patients will receive a maximum of six pieces of gum per day, either containing 50 mg of cannabidiol per piece, in the case of the CanChew® Plus chewing gum, or a placebo chewing gum.
“We are pleased to have enrolled all patients needed and are fully ready to move ahead with the IBS clinical trial,” said George E. Anastassov, MD, DDS, MBA and CEO of AXIM® Biotechnologies. “CanChew® Plus is underway to be the first cannabinoid treatments with pharmaceutical application for the IBS indication, and we anticipate further trials with our pharmaceutical grade chewing gum products to treat indications such as inflammatory bowel disease, ulcerative colitis and Crohn’s disease.”
Dronabinol-Based Chewing Gum Bioequivalent to Marinol
Looking forward, AXIM® is taking the steps to begin development on a functional dronabinol-based chewing gum similar to Marinol using the company’s intellectual property, including their patent on cannabinoid-based controlled release chewing gum.
AXIM® will be creating their new drug using dronabinol, an isomer of THC that was originally used to make Marinol. First introduced in the U.S. market in 1985, Marinol remains the only FDA approved cannabis-based drug available in the U.S. AXIM®’s dronabinol-based gum is intended as a design improvement over Marinol, addressing both safety and efficiency.
Marinol may be prescribed for the treatment of cachexia (weight loss) in patients with AIDS and for the treatment of nausea and vomiting associated with cancer treatment. Marinol is typically reserved for patients who have failed to respond adequately to conventional antiemetic treatments. AXIM® will pursue these same indications in its clinical research on their chewing gum replacement. The total market size for Marinol and generic dronabinol products has reached $150 million for all indications.
AXIM’s patented controlled release chewing gum largely bypasses the first pass metabolism in the liver to the point where AXIM® Biotechnologies believes their new formulation will improve efficacy while simultaneously reducing side effects for patients who utilize this new delivery method.
These are just a few of the ways AXIM® Biotechnologies is rethinking traditional chewing gum and using cannabinoids to address difficult to treat conditions. AXIM® is pursuing new drug status for a number of their unique products. The company has scheduled or started clinical trials for conditions such as Crohn’s disease, restless leg syndrome, dementia, psychosis, Parkinson’s disease, psoriasis and eczema, and glaucoma using other application methods for cannabinoids like topicals or suppositories. AXIM® is planning on running clinical trials on a total of nine new drugs with the earliest new drug applications coming in 2018.
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